Title
Infant Formula Open-Date Marking Guidelines
Law
Bfad Fda Regulation No. 001-c S. 1982
Decision Date
Oct 1, 1982
Guidelines mandate that all powdered infant formula must display a "Best before" date to ensure nutritional quality, specifying limits for moisture content, vitamin C, and solubility, effective January 1983.
A

Q&A (BFAD FDA REGULATION NO. 001-C s. 1982)

The regulation applies to infant food in powdered form (infant formula) intended as a substitute for human milk to meet the normal nutritional requirements of infants.

Infant formula is defined as a product based on milk of cow or other animals (including fish) or plant origin, suitable for infant feeding.

An infant is defined as a person not more than 12 months of age.

Infant formula products must prominently indicate a "Best before" date on their label or package.

It indicates the date at which specified limits such as maximum moisture content, maximum Vitamin C content, and minimum percent solubility are expected to be reached.

The maximum moisture content allowed is 3.5%.

Vitamin C content must be at maximum 90% of the label claim but not lower than 30 mg per 100 mg of sample.

The minimum percent solubility required is 80%.

Full compliance became effective in January 1983.

The regulation was adopted by Catalina C. Sanchez, Acting Administrator, and J. C. Azurin, Minister of Health.


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